CONDYLAFORM II NFC

K060565 · Ivoclar Vivadent, Inc. · ELM · May 8, 2006 · Dental

Device Facts

• Record ID: K060565
• Device Name: CONDYLAFORM II NFC
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: ELM · Dental
• Decision Date: May 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3590
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nanofilled, semi anatomical plastic teeth composed of polymethylmethacrylate intended for use as teeth in full or partial dentures.

Device Story

CONDYLOFORM II NFC are nanofilled, semi-anatomical plastic teeth fabricated from polymethylmethacrylate (PMMA). These devices are intended for use by dental professionals as components in the construction of full or partial dentures. The device functions as a prosthetic replacement for natural teeth, restoring masticatory function and aesthetics for the patient. The device is used in a clinical or laboratory setting by dentists or dental technicians during the denture fabrication process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Nanofilled polymethylmethacrylate (PMMA). Form factor: Preformed semi-anatomical plastic teeth. Classification: Class II, Product Code ELM (Preformed Plastic Denture Tooth).

Indications for Use

Indicated for use as teeth in full or partial dentures for patients requiring prosthetic tooth replacement.

Regulatory Classification

Identification

A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2006

Ms. Danna Marie Hartnett Director of Quality Assurance/Regulatory Affairs Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K060565

Trade/Device Name: CONDYLOFORM II NFC Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: February 21, 2006 Received: March 3, 2006

Dear Mr. Hartnett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a province of approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Page 2 -Ms. Hartnett

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with othar requirements of the Act or any Federal statutes and regulations administered by other Federal ogencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing rogratice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your deveren a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chris Lipe 71-5

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K060565

Device Name: CONDYLOFORM II NFC Indications For Use:

Nanofilled, semi anatomical plastic teeth composed of polymethylmethacrylate intended for use as teeth in full or partial dentures.

Prescription Use t AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of Waar . ... Upli-Cal . In of Anasthestology, General Hoapital, . ... .. Control, Dental Devices C 10(%) Mumber: